Americans could receive a jab to protect them against the coronavirus before Christmas after Moderna found its vaccine is 100 per cent effective at preventing severe cases.
Results from its phase three trial also showed the vaccine, which the US pharmaceutical company designed in just two days, is 94.1 per cent effective at protecting people from the virus.
The first injections could be given as early as December 21 if approval is granted, Moderna chief executive Stéphane Bancel said.
In a statement on Tuesday morning (Australian time), Moderna said it would seek emergency use authorisation from the US Food and Drug Administration.
It comes just over a week after Pfizer applied for the same authorisation.
Moderna’s chief medical officer Dr Tal Zaks said he became emotional when he learnt of the “striking” results from their final trial.
He was quoted by The Associated Press as saying, “it was the first time I allowed myself to cry”.
“We have a full expectation to change the course of this pandemic.”
Moderna will become only the second company to request FDA approval for a COVID-19 vaccine, which would allow its vaccine to be used in emergency cases.
“We have already, just in the trial, have already saved lives. Just imagine the impact then multiplied to the people who can get this vaccine,” Dr Zaks said.
The results from its late-stage trial came from vaccinating 11 of the 196 infected people in its study.
The other 185 received the placebo, 30 of whom had become severely ill. Moderna said the 11 COVID-cases who got the real vaccine were protected by it.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe COVID-19 disease,” the company said.
Moderna said its application for emergency use authorisation would be reviewed by the FDA when its advisory committee meets on December 17.
In the meantime, Moderna said it was preparing to apply for authorisation from the European Medicines Agency on Tuesday.
Rush to get vaccine out within days of approval
US Health Secretary Alex Azar said if the drug-makers were approved, Americans could receive a shot before Christmas.
The US has a plan to start shipping out the drug within 24 hours of approval.
The Food and Drug Administration’s outside advisers will meet on December 10 to consider authorising Pfizer Inc’s COVID-19 vaccine.
That vaccine could be approved and shipped within days, with Moderna’s following a week after, Mr Azar said.
“We could be seeing both of these vaccines out and getting into people’s arms before Christmas,” Mr Azar said on CBS.
He aid the US federal government would ship the vaccines through its normal distribution system, with state governors determining where they should go first.
“They will be determining which groups to be prioritised. I would hope that the science and the evidence will be clear enough that our governors will follow the recommendations that we will make to them,” Mr Azar said.
He said he and Vice-President Mike Pence will speak to all the country’s governors later on Tuesday (Australian time) to discuss the vaccines and which groups of people should get them first.
‘Next phase in the war against COVID’
The White House has moved quickly to take credit for the Moderna vaccine’s development.
“President Trump’s Operation Warp Speed is rapidly advancing on a trajectory of success to save millions of American lives – five times faster than any other vaccine in history,” Mr Trump’s spokesman Michael Bars said in an emailed statement to The New York Times.
The vaccine progress comes at a critical time for the US as authorities brace for a spike in cases following the Thanksgiving holiday, when millions of people travelled to see friends and family.
Hospitals across the country are being stretched to their limits, with more than 160,000 new cases and 1400 new deaths every day in the US.
New York governor Andrew Cuomo said the pandemic had got so bad, that New York city was entering a new phase of the fight, which he likened to a “war”.
“I think of this as a war. It’s a war of attrition … COVID is an enemy that we’re dealing with. It’s attacking people. It’s killing people,” he said.
Mr Cuomo said the city would have to start to lean on retired doctors and nurses if the crisis kept getting worse.
He requested that officials start locating retried health workers to take some of the load off hospitals.
New York had already received help from medical personnel from across the US who travelled to the city last spring. But rising case numbers meant they had to return.
“We’re not going to live through the nightmare of overwhelmed hospitals again,” Mr Cuomo said.
“This was a serious issue last time.”